[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383294":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":64,"collaborators":24,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":24,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":46,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early de-escalation","EXPERIMENTAL","In the experiment arm, empirical antibiotics will be stopped and levofloxacin prophylaxis will be resumed in case of afebrile after 72 hours.",[13],"Procedure: Early de-escalation",{"label":15,"type":6,"description":16,"interventionNames":17},"Standard","In the control group, empirical antibiotics will be continue until recovery of neutropenia or at least 7 days as standard clinical practice.",[18],"Procedure: Standard",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.",[15],[29],{"name":30,"affiliation":31,"role":32},"Jiong hu","Ruijin Hospital","PRINCIPAL_INVESTIGATOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Ling Wang","CONTACT","86-21-64370045","601878","cclingjar@163.com",{"name":41,"role":36,"phone":37,"phoneExt":24,"email":42},"Jiong HU","hj10709@rjh.com.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Blood & Marrow Transplantation Center, RuiJin Hospital","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59,62],{"name":60,"role":36,"phone":37,"phoneExt":24,"email":61},"Jiong HU, M.D.,","hujiong@medmail.com.cn",{"name":63,"role":36,"phone":37,"phoneExt":24,"email":39},"Ling Wang, M.D.,",{"type":32,"investigatorFullName":41,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Head, Blood and Marrow Transplantation Center, Rui Jin Hospital","100383294","early-de-escalation-of-empirical-antibiotics-treatment-for-neutropenic-fever-100383294",false,"NCT04270786","Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever","Phase III Randomized Study of Early De-escalation of Empirical Antibiotics Treatment for Neutropenic Fever in Patients Undergoing Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Age ≥18，patients undergo hematopoietic stem cells\n* Patients with neutropenic fever: T≥38.5°C once or T≥38°C twice a day with ANC \\\u003C0.5x109\u002FL or predicted to be \\\u003C0.5x109\u002FL in 24 \\~48 hours；\n* Patients achieved afebrile （T\\\u003C37.5°C）for at least 72 hours；\n* Inform consent given\n\nExclusion Criteria:\n\n* Patients with neutropenic fever with documented blood stream infection, skin and soft tissue infection, pneumonia and catheter associated infection.\n* Patients with septic shock\n* Levofloaxin allergy or contra-indication","ALL","18 Years","65 Years",{"count":77,"type":78},200,"ESTIMATED","INTERVENTIONAL",[81],"NA","This is a randomized study to evaluate the safety and feasibility of early de-escalation of empirical antibiotics treatment in neutropenic fever patients undergoing hematopoietic stem cell transplantation (HSCT). In case of afebrile for 72 hours with empirical antibiotics treatment, patients will be randomized into 2 groups. In the early de-escalation group, antibiotics treatment will be stopped and prophylaxis with levofloxacin will be resumed. In the control group, the empirical treatment will continue until recovery of neutropenia or at least for 7 days.",[84],"Safety Issues",[86],"neutropenic fever, empiric, antibiotics","2025-02-14",{"date":89,"type":90},"2025-02-18","ACTUAL",{"date":92,"type":90},"2020-01-01",{"date":94,"type":78},"2026-06-30",{"name":5,"class":6},1]